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The U.S. Food and Drug Administration (FDA) is informing health care professionals of a Class I Recall of HeartWare Ventricular Assist Systems (VAS):

Device Models: 1400, 1401XX

Control Serial Number: CON000001 through CON005472

Manufacturing Dates: March 2006 through October 2012

The devices were distributed from March 2006 to February 2014 during the ADVANCE (August 2008 - August 2013) and ENDURANCE (October 2013 - Present) clinical trials.

The HeartWare VAS helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant.

The recall was initiated because a buildup of static may cause a sudden electrostatic discharge in the device. When this happens, data in the motor controller that manages the pump's operation may be corrupted and the device may stop working. This problem occurs more often in older model controllers distributed during the clinical trials. If the pump stops working, it can lead to serious adverse health consequences, including death.

Patients with questions about this recall should be instructed to contact their health care provider or the VAD (Ventricular Assist Devices) Coordinator at their hospital center.

Health care providers who want to return affected devices or have questions about the recall should contact their HeartWare representative, or contact HeartWare 24-hour Clinical Support at 888-494-6365, or emailFSCA@heartware.com.

On February 20, 2015 HeartWare sent an "Urgent Medical Device Recall" letter to their customers advising health care providers to:

Identify patients with the affected device

Review the risks of electrostatic discharge with patients, including telling patients how to reduce the risk of electrostatic discharge by avoiding:

Dry environments

Certain fabrics and materials, such as silk clothing and carpeting

Electronic devices prone to static electricity

Activities, such as vacuuming and removing clothes from a dryer

Exchange the recalled controller for a new controller, if medically advisable. The exchange should take place in a controlled setting under medical supervision. Controllers should be exchanged for a new controller with a serial number of CON005473 or higher.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a memorandum on the potential adverse impact of lower relative humidity (RH) in operating rooms (ORs). According to CMS, regulations governing hospitals and CAHs require compliance with the 2000 Edition of the National Fire Protection Association (NFPA) 101: LSC, including the mandatory references of the LSC, such as the 1999 Edition of NFPA 99: Health Care Facilities. The NFPA 99 requires that mechanical ventilation systems supplying hospital anesthetizing locations, as defined by NFPA 99, have the capability of controlling RH at a level of 35 % or greater.

In April 2013 CMS issued a categorical waiver (S&C 13-25-LSC & ASC) to the above regulations which permits hospitals and CAHs with new and existing ventilation systems supplying anesthetizing locations to operate with a RH level of 20 % or greater in accordance with American Society for Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE) Standard 170, Ventilation of Health Care Facilities. Lowering the required minimum RH level to 20 % was intended to provide adequate humidity levels for patient health and safety, while alleviating unreasonable hardship on healthcare facilities. Note that Ambulatory Surgical Centers (ASCs) are not subject to all of the same LSC provisions as hospitals and CAHs, and thus the categorical waiver is not needed in an ASC that chooses to use lower RH in its ORs.

It has subsequently come to light that an RH level <30% is not compatible with the instructions for use (IFUs) for some sterile supplies and electro-medical equipment used in operating rooms. Multiple health-care related organizations convened by AAMI in 2014 to discuss this topic came to a consensus and released a Joint Communication on January 5, 2015; a link to that communication is below.

Among other things, the Joint Communication notes that:

While manufacturers of supplies and equipment will be expanding the lower level of the RH range in which their products may function to 20%, the pace of this change is likely to take time.

For facilities that continue to use older equipment it could be many years before this older equipment is replaced and all of the equipment they use will function appropriately at lower RH levels.

The Joint Communication offers a number of useful questions health care facility leadership should ask when assessing the risk of reducing RH in their ORs in light of the potential impact on equipment and supplies.

At this time CMS expects hospitals, CAHs and ASCs to follow the current IFUs for supplies and equipment used in their ORs. Failure to adhere to the IFUs must be cited, even if the facility has opted to use the categorical waiver of the LSC RH requirements. Citations would fall under §482.41(c)(2) for hospitals, §485.623(b)(1), for CAHs, and §415.44(a)(1) for ASCs.

The Clinical Standards Group (CSG) in the U.S. Centers for Medicare and Medicaid Services (CMS) Center for Clinical Standards and Quality (CCSQ) is responsible for developing, updating and overseeing the CMS regulations on the Conditions for Coverage (CfCs) for end stage renal disease (ESRD) facilities.

According to CSG, the current ESRD regulations were last revised in 2008; therefore, CSG is asking the ESRD community to review the current Conditions for Coverage (CfCs) and provide suggestions for additions/changes/obsoletions that may be useful in a future update to the current regulations.

At this time there is no deadline for this comment period. Follow the link below to access the current ESRD CfC's. CSG is requesting that suggestions for future updates to the CMS regulations on the Conditions for Coverage (CfCs) for ESRD facilities be emailed to ESRDCSG@cms.hhs.gov.

Featured Policy Library Manuals

MCN’s Utilities and Equipment Management Policy and procedure Manual is a reference guide that is compliant with Joint Commission, NIAHO and CIHQ standards and CMS regulations. MCN provides easy-to-use policies and procedures that are field tested and proven - you need only to customize them to your healthcare organization. Policies and procedures include Utility Systems Management Plan, Alternative Equipment Maintenance Program, Clinical Alarms, Emergency Power and much more!

MCN Healthcare’s Administrative Manual for Critical Access Hospitals is specifically designed to assist critical access hospitals meet CMS, TJC and NIAHO standards for CAHs. This manual provides over 275 ready-to-implement policies, procedures and forms in an easy-to-customize Word format, and is designed to demonstrate compliance with CAH regulations. Transplant Safety polices are also included in this manual.

MCN's NEW Ambulatory Surgical Center/Outpatient Surgery Department Policy and Procedure Manual is cross referenced to TJC standards, AAAHC standards and CMS regulations. Policies and procedures meet AORN and CDC recommendations and guidelines. This comprehensive reference guide has over 290 policies and procedures that are ready to customize to your organization. See also the Administrative Manual for Ambulatory Care Facilities and the Ambulatory Services EOC Manual.